We believe the collection, monitoring and management of data are crucial to quality research and science
We offer the following data management services:
Data Selection: We provide guidance related to what information should be captured on electronic case report forms or collected via separate applications (such as specimen tracking) to meet your research objectives.
Data Collection: CRAB has a proprietary, 21 CFR Part 11 compliant, Electronic Data Capture (EDC) System that reliably and consistently collects the data you require for your study. We offer customizable electronic case report forms, complete with standard and custom edit checks, as well as system generated queries.
Data Review: Centralized monitoring, as defined in the FDA Guidance for Industry – A Risk-Based Monitoring Approach to Monitoring, is our specialty. We assure that studies meet statistical requirements and study objectives by verifying adherence to study guidelines for eligibility, treatment administration, treatment response and safety reporting. Our in-house data coordinators/monitors are skilled at identifying incongruities not found by edit checks alone; we enter and track manual queries to sites and are available to communicate directly with site staff to provide further clarification as to the data requirements.
Data Metrics: We build and deliver reports critical to the overall management of your study.
Data Protection: Our state-of-the-art data center keeps your electronic data safe and secure at all times. In addition, we routinely back-up your data to an off-site location as part of our disaster preparedness plan.